Pain Intensity differences at rest, on motion and of overall assessment using a VAS scale at each follow-up assessments time point through Day 28. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

The objective of this study is to demonstrate the short-term multiple dose efficacy and safety of HKT-500 in subjects with pain caused by mild to moderate osteoarthritis of the knee. The goal of the study is to gather additional information about the analgesic efficacy and safety of repeated, 24-hour applications of 2 HKT-500 patches per knee for a total of 28 days in subjects with pain caused by mild to moderate osteoarthritis of the knee.

Eligibility

Ages Eligible for Study:

45 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

man or woman ≥45 years of age.

clinical diagnosis of unilateral or bilateral OA of the knee

taking an NSAID or acetaminophen on a regular basis and has a history of knee pain amelioration with NSAID or acetaminophen use.

mild to moderate OA of the knee at the screening visit

subject exhibits an arthritis "flare" in the target knee within 7 days day of withdrawing from a NSAID or acetaminophen.

subject understands that treatment will be administered on an inpatient basis.

subject is capable of understanding and complying with the protocol and has signed the informed consent document.

Exclusion Criteria:

subject is a woman of childbearing potential who has a positive urine pregnancy test, is lactating, or who is not surgically sterile

subject has symptoms that are attributable to primary inflammatory diseases of the joint

subject has unstable knees including a history of the knee catching or giving way or physical examination evidence of instability

subject has arthropathies that occur in conjunction with systemic diseases

subject has a chronic pain condition

subject is grossly obese

subject has a history of knee surgery within the past 12 months or arthroscopy within the past 6 months.

subject has a history of osteotomies.

subject is not willing to discontinue the use of NSAIDs, acetaminophen or other prohibited treatments

subject used opioids for OA pain within 1 month

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00792727